BACKGROUND
Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values, obtained through innovative permanent intra-cardiac micro-sensors ("embodied"), has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization, hoping to reduce patients´ hospitalization rate and optimize their quality of life.
OBJECTIVE
The present manuscript has focused on the analysis and interpretation of an empirical survey evaluating usability and patients’ attitudes towards a new permanent intra-cardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP™, Vectorious Medical Technologies, Tel Aviv, Israel) of chronic HF patients.
METHODS
The V-LAP system is a miniaturized sensor implanted totally percutaneously across the inter-atrial septum. It communicates wirelessly with a "companion device" (a wearable belt) that is placed on the patient's chest at the time of acquisition /transmission of left heart pressure measurements. At first follow-up after implantation the patients and the health care providers were asked to fill out a questionnaire on the usability of the system, the ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent).
RESULTS
Use and acceptance of in-body technology from the first 8 patients implanted with the V-LAP technology worldwide have been analysed. No peri-procedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after the device implantation with the participation of patients and health care providers. A pre-determined appropriate measurement position for the external measuring unit (thoracic belt) was identified before discharge to guarantee, for each patient, good communication with the internal cardiac sensor and via wireless/RF communication. At the first follow-up, the overall comfort in technology use was 3.7±1.3 with 87.5 % (7/8) of patients succeeding in applying and operating the system independently. An average score of 3.5±1.4 points was given to the ease in positioning the external measuring belt in the pre-determined measurement position. All health care providers (8/8) were able to support patients with the technology. Health care providers’ average overall ease and comfort in operating the system was 3.8± 0.8 points with 4.1±0.8 points for the ease in positioning the thoracic belt in the appropriate measuring position.
CONCLUSIONS
Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases they can correctly and consistently acquire and transmit hemodynamic data. The overall patient/care provider satisfaction with the V-LAP system seems to be high. Patients and respective health care providers have reported a score between average to good when assessing the ease in performing simple but crucial tasks such as wearing and fastening the thoracic belt and more specifically in consistently finding its appropriate position for ideal measurements. Improvements in the external thoracic belt design have been very recently introduced and will hopefully further optimize patients´ and health care providers´ acceptance and adoption of this technology.
CLINICALTRIAL
NCT03775161